Ann: AFT update on Maxigesic IV US registration filing, page-2

I had a quick look on the Hyloris website and IMO they seem confident that this is something which can be sorted without too much trouble. It's strange that Maxigesic IV is already licensed and being used in many other countries, yet the FDA seems to be throwing up roadblocks to slow down it's use in the USA. After all, my understanding is that the USA arguably has the biggest opioid problem of them all, and this is what Maxigesic IV can help reduce in the future. Looks to me like Maxigesic IV is in glass bottles anyway, what are they thinking will "leach" out of glass?

Here's the line from the Hyloris website:
"As previously stated, this request required by the FDA falls well within the parameters of our normal operational budget and can be completed expeditiously, requiring no additional clinical data to be generated. Hyloris remains committed to Maxigesic IV®"